Free Handbook
SQA Solution Handbook: IT Validation, Quality, and Compliance for Clinical-Stage Pharma
This handbook is for people who own IT compliance, validation or quality oversight at a clinical-stage pharma or biotech company.
It helps QA, IT, Clinical Ops and Regulatory professionals build risk-based, audit-ready validation programs. It covers digital infrastructure and clinical manufacturing compliance.
What’s inside
- Foundational GxP expectations
- Implementing FDA's Computer Software Assurance (CSA) methodology
- Integrating GAMP 5 best practices
- Managing vendors
- Overseeing change control
- Building inspection-ready systems